---
kind: "section"
citation: "21 C.F.R. § 862.2270"
title: "21"
number: "862.2270"
heading: "Thin-layer chromatography system for clinical use."
url: "https://uscodex.org/cfr/21/862.2270"
---

# §862.2270. Thin-layer chromatography system for clinical use.

- (a) **Identification.** A thin-layer chromatography (TLC) system for clinical use is a device intended to separate one or more drugs or compounds from a mixture. The mixture of compounds is absorbed onto a stationary phase or thin layer of inert material (e.g., cellulose, alumina, etc.) and eluted off by a moving solvent (moving phase) until equilibrium occurs between the two phases.
- (b) **Classification.** Class I (general controls). The device is exempt from the premarket notification procedures in [subpart E of part 807](/cfr/21/part807-subpartE.md) of this chapter subject to [§ 862.9](/cfr/21/862.9.md). Particular components of TLC systems, i.e., the thin-layer chromatography apparatus, TLC atomizer, TLC developing tanks, and TLC ultraviolet light, are exempt from the current good manufacturing practice requirements of the quality management system regulation in [part 820](/cfr/21/part820.md) of this chapter, except for requirements concerning records and complaint files under [§ 820.35](/cfr/21/820.35.md) of this chapter.

## Notes

### Amendments

[52 FR 16122, May 1, 1987, as amended at 65 FR 2309, Jan. 14, 2000; 90 FR 55980, Dec. 4, 2025]

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 52 FR 16122, May 1, 1987, unless otherwise noted.

### Amendments

[52 FR 16122, May 1, 1987, as amended at 65 FR 2309, Jan. 14, 2000; 90 FR 55980, Dec. 4, 2025]